Rapporteur’s

<Preliminary> <Final> Assessment Report

for paediatric studies submitted in accordance

with Article 45 of Regulation (EC) No1901/2006, as amended

<(Active Substance)>

<Product name(s)>

XX/W/{nnnn}/pdWS/{nnn}

Rapporteur:
Start of the procedure (day 0):
Date of this report:
Deadline for Rapporteur’s preliminary paediatric assessment report (PPdAR) (day 70):
Deadline for CMS’s comments (day 85):
Date re-start procedure (day 90):
Deadline for CMS’s comments (day 115):
Finalisation procedure (day 120):

TABLE OF CONTENTS

I.Executive Summary......

II.Recommendation

III.INTRODUCTION......

IV.SCIENTIFIC DISCUSSION......

IV.1Information on the pharmaceutical formulation used in the clinical study(ies)

IV.2< Non-clinical aspects>

IV.3<Clinical aspects>

V.Rapporteur’s Overall Conclusion AND RECOMMENDATION......

VI.<Assessment of response to questions>......

VII.<Final Rapporteur’s Overall Conclusion AND RECOMMENDATION>......

VIII.List of Medicinal products and marketing authorisation holders involved......

ADMINISTRATIVE INFORMATION

Invented name of the medicinal product(s): / See section VIII
INN (or common name) of the active substance(s):
MAH(s): / See section VIII
Pharmaco-therapeutic group
(ATC Code):
Pharmaceutical form(s) and strength(s):
Rapporteur’s contact person: / Name
Tel:
Email:
Name of the assessor(s) / Name:
Tel:
Email:

I.Executive Summary

<SmPC and PL changes are proposed in sections xxxx and xxxx.>

<No SmPC and PL changes are proposed.>

Summary of outcome

Note: When ticking the change box, only one of the subsequent boxes with regard to the classification of the change must be ticked.

No change

Change

New study data: <section(s) xxxx, xxxx>

Note: Mention sections with regard to the addition of new clinical data. For example data, which

has been included in 5.1, 5.2 or preclinical (juvenile tox data) in 5.3>.

New safety information: <section(s) xxxx, xxxx>

Note: Mention sections with regard to the addition of new safety information. For example when new Adverse Drug Reactions (ADRs) are included in section 4.8 or additional data in sections 4.3/4.4.

Paediatric information clarified: <section(s) xxxx, xxxx>

Note: Mention sections which further clarify existing recommendations on paediatric use.

New indication: <section(s) xxxx, xxxx>

Note: i) A new paediatric indication as reflected in section 4.1 of the current SmPC guideline

and/or ii) addition of a paediatric dose recommendation in section 4.2 for an indication already

granted in adult or in one or more subsets or for a new indication. Other relevant sections with

regard to the change should be mentioned.

II.RecommendatioN[1]

III.INTRODUCTION

Several MAHs submitted < number’X’ > completed paediatric study(ies) for active substance>, in accordance with Article 45 of the Regulation (EC)No 1901/2006, as amended on medicinal products for paediatric use.

(A short critical expert overview has also been provided.)

The MAH stated that the submitted paediatric study(ies) <do(es) not> influence the benefit risk forname of the medicinal product> and that there is <no> <a> consequential regulatory action.

<The MAH proposed the following regulatory action:description of proposed amendments to the sections of the product information

In addition, the following documentation has been included as per the procedural guidance:

-A line listing

-<An annex including SmPC wording of sections 4.1 and 4.2 related to the paediatric use of the medicinal product, and related PL wording>

IV.SCIENTIFIC DISCUSSION

IV.1Information on the pharmaceutical formulation used in the clinical study(ies)

Note : Information on the pharmaceutical formulation used in the study(ies), the existence of a paediatric formulation, or conditions for extemporaneous formulations if applicable, should be mentioned here.

IV.2< Non-clinical aspects>

1. Introduction

Note: A list of all the non-clinical studies submitted with a brief description for each study should be included (see line-listing provided by the MAH).

The MAH submitted <a> report(s) for:

-study number and title>;

-study number and title>;

The MAH submitted <an> extended synopsis for:

-study number and title>;

-study number and title>;

2. Non clinical study(ies)

Note: For each non-clinical study, the following structure is recommended

<NON CLINICAL STUDY NUMBER and TITLE >

Description

Methods

  • Study design
  • Species/strain/age
  • Dose

Results

3. Discussion on non clinical aspects and conclusion

IV.3<Clinical aspects>

1. Introduction

Note: A list of all the clinical studies submitted with a brief description for each study should be included (see line-listing provided by the MAH)

The MAH submitted <a> report(s) for:

-study number and title>;

-study number and title>;

The MAH submitted <an> extended synopsis for:

-study number and title>;

-study number and title>;

2. Clinical study(ies)

Note: For each clinical study, the following structure is recommended. Assessors should consider if safety results should be discussed in the context of post-marketing safety data, liaising with pharmacovigilance colleagues if necessary.

<CLINICAL STUDY NUMBER AND TITLE>

Description

Methods

  • Objective(s)
  • Study design
  • Study population /Sample size
  • Treatments
  • Outcomes/endpoints
  • Statistical Methods

Results

  • Recruitment/ Number analysed
  • Baseline data
  • Efficacy results
  • Safety results

3. Discussion on clinical aspects and conclusion

Note: Any relevant Pharmacovigilance information related to the active substance should be mentioned and discussed in this section.

V.Rapporteur’s Overall Conclusion AND RECOMMENDATION

Note:

- Please ensure that the final conclusion does not contain references to individual Member States. "If a type IB variation is recommended, please specify the texts proposed for inclusion in the relevant SmPC and PL sections.

- If different formulations have been included in the paediatric worksharing;formulation-specific recommendations for each of the formulations should be stated separately, e.g. warning statement with regard to differing excipients.

Overall conclusion

Recommendation

<No further action required>

<Type IB variation to be requested from the MAH by <date>

<Based on the data submitted, the MAH should provide <description of the additional clarifications requested per study>[2] as part of this worksharing procedure. (see section VI “Request for supplementary information”)

VI.REQUEST FOR SUPPLEMENTARY INFORMATION

< Not applicable>

Or

<List of questions>

VII.<Assessment of response to questions>

VIII.<Final Rapporteur’s Overall Conclusion AND RECOMMENDATION>

Overall conclusion

Recommendation

<No further action required>

<Type IB variation to be requested from the MAH by <date>

IX.List of Medicinal products and marketing authorisation holders involved

The list can be taken from the spreadsheet compiled from the EMA

<active substance>

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[1]The recommendation from section V can be copied in this section.

[2] Directly linked to the study(ies) submitted